Drug & Alcohol Newsletter Issue 30

U.S. Department of Transportation
Federal Transit Administration
Office of Safety and Security

FTA Drug And Alcohol Regulation Updates
Fall 2005
Issue 30

Introduction....

The Federal Transit Administration (FTA) published its revised rule on prohibited drug use and the prevention of alcohol misuse (49 CFR Part 655) on August 1, 2001. The FTA published the revised Implementation Guidelines for Drug and Alcohol Regulations in Mass Transit to provide a comprehensive overview of the regulations.

Since the Guidelines were published, there have been numerous amendments, interpretations, and clarifications to the Drug and Alcohol testing procedures and program requirements.

This publication is being provided to update the Guidelines and inform your transit system of these changes. This Update is the thirtieth in a series.

Inside....

FTA Drug & Alcohol Program National Conference Announced

FTA announced that the first Drug and Alcohol Program National Conference will be held on March 20-21, 2006 at the Hampton Inn Tropicana, in Las Vegas, NV. A block of rooms will be available for attendees. The Conference will bring together experts in the field to discuss issues related to the FTA Drug and Alcohol Testing regulations (49 CFR Part 655) and the DOT Procedures for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR Part 40).

The two-day conference will include introductory comments from Jerry Powers of the FTA Office of Safety and Security and Mark Snider from the Office of Drug and Alcohol Policy and Compliance (ODAPC). Breakout sessions will cover such topics as: How Random is Your Testing Program?; The Role of the MRO and SAP; Testing Thresholds; Collection Demonstrations; Contractor, Service Agent and State Oversight and many others. Some sessions will be targeted for seasoned program managers while others will target those new to the field.

In addition to the breakout sessions, technical assistance tables will be available where you can have your policy reviewed, enter and review your MIS report on line, or obtain hard copy and electronic versions of resource materials. Participants will have numerous opportunities to get questions answered and to interact with policy makers, auditors and experts in the field. Attendance at the conference will be beneficial to transit agency drug and alcohol program managers, human resource managers, safety managers, union representatives, safety-sensitive contractors and service agents providing services to the transit industry. Conference cost is free. Registration information will be announced on the FTA Website, in mailings and in future editions of this newsletter.

2002 Annual Report Published

The seventh annual report of FTA’s drug and alcohol testing program covering the 2002 reporting year is now available from FTA’s Website or through the National Technical Information Service (see resource list on back page). The report summarizes the data reported from a stratified random sample of rural, small urban, and large urban transit systems and reports the random drug and alcohol violation rates for calendar years 1996 - 2002. Statistics are presented for each of the testing categories, employer type, employer size, employee category, FTA region and substance type.

In 2002, the official drug violation rate for random tests rose by 7% to 1.05% and the official alcohol violation rate rose by more than 20% to 0.22%. Marijuana was detected more often than all the other drugs combined for random and reasonable suspicion tests. Marijuana was detected most often in post-accident tests, and cocaine was a close second. Cocaine was detected more often than the others combined for pre-employment tests while marijuana was detected in fewer than twenty percent of the pre-employment tests.

The random drug and alcohol violation rates were significantly higher for contractors than for transit agencies. Contractor employees had over two times as many drug positives and nearly four times as many positive alcohol test results. Small urban transit systems had nearly double the positive drug test results as the rural and large urban systems. Alcohol test results were similar for the different employer sizes. New England had the lowest drug violation rate (0.62%) while the Middle Atlantic states had the highest rate (1.32%). The lowest alcohol violation rate was in New York/New Jersey and the highest was in the central states of Iowa, Missouri, Kansas and Nebraska.

Internet Reporting a Success

Over 85% of transit agencies reported the data for their 2004 Drug & Alcohol Management Information System (MIS) report via the internet. Use of the Internet improved the speed and accuracy of the data reporting process resulting in time and cost savings.

One Page MIS Form

The information presented on this page should be used to update Chapter 7 of the revised Implementation Guidelines. GAO Addresses Drug Test Defraud Issue

On May 17, 2005 the United States Government Accountability Office published a report (GAO-05-653T) entitled “DRUG TESTS: Products to Defraud Drug Use Screening Tests Are Widely Available.” The report consists of testimony by Robert J. Cramer, Managing Director of the Office of Special Investigations made to the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce of the House of Representatives.

The testimony described the current situation where products to defraud drug tests are easily obtained and openly marketed on Web sites. Vendors boast that their products will not be detected in the drug test process and that their customers will pass impending drug tests regardless of their purported use of illegal substances. Some products are formulated to defraud tests for marijuana while others are targeted at cocaine. Some vendors provide money-back guarantees.

Masking products fall into four categories: (1) substances that when added to a specimen or ingested dilute the specimen; (2) cleansing substances that detoxify or cleanse the urine; (3) adulterants that destroy or alter the chemical make-up of drugs; and (4) synthetic or drug-free urine that is used as a substitute for an individual’s own specimen. There are a tremendous number of products available on the market with the investigators identifying approximately 400 different products alone that are available to adulterate urine specimens.

Even though these efforts to defraud the drug testing process represent formidable obstacles to the integrity of drug testing, the DOT process (defined in 49 CFR Part 40) combined with permitted validity testing will thwart most, if not all of these products. The report quoted SAMSHA officials as stating “validity tests are intended to produce accurate, reliable, and correctly interpreted test results and to decrease or eliminate opportunities to defeat drug tests.” Validity Testing Permitted, Not Required

Efforts to beat drug tests have been well publicized in the popular press as well-known sports figures have been found to use various products that are readily available off the internet. Validity testing is one of the best defenses that Department of Transportation (DOT) covered employers have at their disposal to maintain the integrity of the drug testing process. Validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine or if certain adulterants or foreign substances were added to the urine, the urine was diluted, or the specimen was substituted.

The DOT issued an interim final rule (IFR) on November 9, 2004 making 49 CFR Part 40 consistent with the new validity testing requirements established by the Department of Health and Human Services (DHHS). The IFR established laboratory criteria for validity testing, standardized terms, defined MRO responsibilities, and established reporting requirements. The DOT IFR authorizes, but does not require laboratories to perform specimen validity testing.

Many people erroneously assume that validity testing is a requirement of the regulation and have a false sense of security that efforts to defraud their drug testing process are in place. This is not necessarily true. The IFR requires that laboratories that conduct specimen validity testing of DOT specimens must do so in accordance with the testing requirements specified in the rules, but stops short of making the testing mandatory. Many of the DHHS certified laboratories do not currently perform validity tests as part of their standard operating procedure. Unless you have specified in the agreement with your laboratory that you want validity testing conducted, validity testing may not be performed, leaving your program vulnerable to defraud efforts.

Before the IFR becomes final, the industry anticipates that the DOT will issue a Notice of Proposed Rulemaking that will propose to make specimen validity testing mandatory within the regulated transportation industries. Until such time as validity testing becomes mandatory, you are on your own to work with your laboratory to determine if validity testing should be a part of your program.

TECHNICAL ASSISTANCE

FTA Drug and Alcohol Regulation Updates
Issue 30, page 3

FTA/ODAPC Provides Assistance

Since the drug and alcohol testing regulations were first promulgated, the Federal Transit Administration (FTA) and the Office of Drug and Alcohol Policy and Compliance (ODAPC) have provided a wide array of technical assistance to help covered employers comply with the regulations. The technical assistance tools have included procedural manuals and reports, training workshops, videos, seminars, and Web-based resources. A list of these resources and how they can be obtained is provided on the back page of this newsletter. Several new tools have been created to address common problems. These tools include: A policy checklist that was updated in June of 2005. The checklist can be downloaded from FTA’s website. The checklist lists all of the elements that must be included in a compliant drug and alcohol testing policy. Go to http://transit-safety.volpe.dot.gov.

A credit card sized post-accident decision reference guide that can hang from an ID lanyard or tucked into a wallet. The easy-to-use reference defines the FTA post-accident thresholds, describes who to test, and outlines the time limitations for post-accident testing. A sample guide can be obtained by e-mailing: fta.damis@volpe.dot.gov.

The leader’s guide for the Reasonable Suspicion Referral for Drug and Alcohol Testing was updated and reprinted. The video has not been updated. The guide can be obtained by calling the FTA Office of Safety and Security Clearinghouse at (617) 494-2108.

The Office of Drug and Alcohol Policy Compliance (ODAPC) announced the release of a new publication entitled What Employees Need to Know About DOT Drug and Alcohol Testing. This guide presents the basics every safety-sensitive employee should know about the DOT drug and alcohol testing regulations. This seventeen page guide can be downloaded at www.dot.gov/ost/dapc/documents.html.

In addition to these tools, the ODAPC has begun a subscription service to provide news and updates by e-mail. Subscribers receive news, updates and information related to DOT’s Workplace Drug and Alcohol Testing Procedures. To subscribe to this service, go to www.dot.gov/ost/dapc/email_list.html and fill out the required information. In addition to the subscription service, information can be obtained from the ODAPC website at www.dot.gov/ost/dapc/news.

Substance Abuse Seminars to be Scheduled

Given the success of the Substance Abuse Seminars that FTA has conducted over the past five years, FTA has decided to offer additional sessions this year. The one day seminars are designed to provide essential information and insight to facilitate employers’ compliance with FTA’s drug and alcohol testing regulations. The seminars update participants on regulatory changes, interpretations, agency best practices, and guidance on how to address prescription and over-the-counter medication use in a safety-sensitive work environment. The sessions have proven beneficial to transit agency drug and alcohol program managers, human resource managers, safety mangers, safety-sensitive contractors and service agents proving services to the transit industry.

To host a seminar, you must provide an accessible meeting location with a capacity of 100 people or more, provide audio-visual equipment, assist in publicizing the training session, and assist with registration. The dates and locations of the seminars will be announced as soon as host sites are confirmed. To register for a session or to volunteer to be a host site, contact Felicity Shanahan at (617) 494-6336.

The Transportation Safety Institute (TSI) has published its list of course offerings for the next fiscal year. TSI provides a two and one-half day substance abuse management course as part of its core curriculum. The course assists participants with conducting an evaluation and self-assessment of their respective agency’s substance abuse program and compliance with FTA regulations. The last class in 2005 is scheduled for Cleburne, TX on November 15-17. In 2006 classes are scheduled for Miami, FL on February 7-9; San Antonio, TX on February 28-March 2; Los Angeles, CA on April 18-20; and, Houston, TX on April 26-28. For more information and to register for a class, call (405) 954-3682.

REGULATORY CLARIFICATIONS

Where to Find? ..... DHH Labs

The current list of DHHS certified labs is published the first week of each month and is printed in the Federal Register under the Substance Abuse and Mental Health Services Administration (SAMHSA) heading. Only those labs certified can be used for FTA drug testing. The list should be checked monthly as new labs are being added and others are being removed. Website location: www.workplace.samhsa.gov/ResourceCenter/lablist.htm
To verify the certification status of a laboratory, DHHS has established a telephone HELPLINE (800) 843-4971.

The information presented on this page should be used to update Chapters 7 and 8 of the revised Implementation Guidelines.

Previous DOT Test Record Request Clarified

The DOT drug and alcohol testing rule (49 CFR Part 40.25) states that all covered employers must make a good faith effort to obtain DOT drug and alcohol testing records for the previous two years for all applicants seeking safety-sensitive positions. This requirement has been the source of confusion and therefore, the following clarifications are provided. The authority for this requirement for FTA covered employers comes directly from 49 CFR Part 40.25, not FTA. Consequently, employers should not refer to FTA or Part 655 in their request for information. The suggested format for the “Release of Information” was provided in Issue 22, page 3 of the Updates.

Part 40.25 also requires employers to ask all applicants/transfers whether he/she has tested positive, or refused to test within the past two years on any DOT pre-employment drug or alcohol test administered by a DOT-covered employer for which they were not hired. Consequently, this question must be incorporated into the application process. Many transit systems have been deemed non-compliant because they failed to implement this provision of the requirement.

The Federal Motor Carrier Safety Administration (FMCSA) requires employers that are covered by 49 CFR Part 391.23 to request information for a three-year period rather than the two years required by the DOT. Since the FMCSA rule exceeds the DOT rule requirements, employers that meet the FMCSA rule are considered to be compliant with the DOT rule as long as the request for information that the employee signs clearly defines the period of coverage.

CCF/ATF Errors Cause Compliance Problems

Occasionally employers and/or Third Party Administrators (TPA) use outdated Custody and Control Forms (CCF) with the wrong laboratory or Medical Review Officer (MRO) listed. When this occurs, urine specimens are being sent to the wrong laboratories and results are being sent to the wrong MRO. Similarly, TPAs sometimes use their own identifying information on the CCF and do not complete the employer-specific information as required. Not only is this practice a violation of the regulations (49 CFR Part 40.45(c)(2)), but it may also result in test results being sent to the wrong employer with corresponding time delays and confidentiality compromises. To remedy these situations, review CCF forms to ensure that all necessary information is provided on the form and that it is correct and up-to-date.

If a screen test for alcohol results in an alcohol concentration of 0.02 or greater, a confirmation test must be performed.

The confirmation test must be conducted at least 15 minutes, but not more than 30 minutes, after the completion of the screen test. The Breath Alcohol Technician (BAT) is required to indicate on the Alcohol Test Form if the fifteen minute delay between the initial screen and the confirmation test was met by marking the appropriate “yes” or “no” box. One of these boxes should be completed only if a confirmation test is required. Neither box should be checked if a confirmation test is not required. If a box is checked in error, this would be considered an audit compliance finding.

Consumer Alert on Breath Testing Devices

The Office of Drug and Alcohol Policy and Compliance (ODAPC) published a consumer alert cautioning against the use of the “Alcohol v” disposable breath alcohol screening device manufactured by Akers Biosciences, Inc. of Thorofare, NJ. Recent testing by the National Highway Traffic Safety Administration (NHTSA) found that the device had been substantially modified, resulting in false positive and false negative test results and was no longer in compliance with NHTSA requirements for a breath screening device. Given this finding, ODAPC asks that all regulated employers not use any of the Akers “Alcohol v’’ alcohol screening devices. [Top]

Page 5

REGULATORY CLARIFICATION

FTA Drug and Alcohol Regulation Updates
Issue 30, page 5

SAP Compliance is Transit System’s Responsibility

All FTA recipients/subrecipients covered under the FTA drug and alcohol testing regulations are ultimately responsible for the quality and compliance of their programs. This responsibility includes the monitoring and oversight of all service agents including your Substance Abuse Professionals (SAPs). Every employer who performs DOT drug and alcohol testing must be able to provide a list of qualified SAPs to every employee and applicant who tests positive or refuses a test. This information must be provided even if the employer’s policy is to discharge employees who violate their drug and alcohol policy. A SAP must be a professional listed by name and can not be a facility, treatment program, or medical practice. The term “Substance Abuse Professional” has become a generic term used in the counseling industry to mean anyone that provides substance abuse counseling. This loose use of the title has resulted in significant confusion and misunderstanding among DOT covered employers and the substance abuse counseling industry. Many people may be professionals that address substance abuse, but few are Substance Abuse Professionals as defined by DOT (49 CFR Part 281).

To be a qualified SAP for a Federal drug and alcohol testing program, the individual must meet the following minimum requirements.

A SAP must be a licensed physician (Doctor of Medicine or Doctor of Osteopathy); or a licensed or certified psychologist; a licensed or certified social worker; or a licensed or certified employee assistance professional; or a Master Addiction Counselor (MAC) certified by the National Board for Certified Counselors, Inc. and Affiliates (NBCC), or an alcohol and drug abuse counselor certified by the National Association of Alcoholism and Drug Abuse Counselors Certification Commission (NAADAC), or by the International Certification Reciprocity Consortium /Alcohol and Other Drugs (ICRC).

The SAP must have knowledge of and clinical experience in the diagnosis and treatment of substance abuse-related disorders, and must have knowledge of the SAP’s role in the protection of public safety.

Previously practicing SAPs must have completed qualifications training by December 31, 2003. New SAPs entering into practice after this date must have received training before they perform SAP duties.

Following the qualifications training, the individual must satisfactorily complete an examination that is given by a nationally recognized professional or training organization.

SAPs must also successfully complete twelve hours of professional development training every three years. The professional development training is usually obtained in the form of continuing education credits that are relevant to the performance of SAP functions. At a minimum, the continuing education must address new drug and alcohol abuse technologies, current DOT and modal rule changes and interpretations, DOT provided SAP guidance, and other information about the SAP function and how it relates to the DOT testing program. The continuing education program must provide a documented assessment of SAP knowledge.

SAPs must maintain documentation demonstrating their compliance. Transit system drug and alcohol program managers should request this information and verify that it is compliant. Special attention should be given to dates of the initial qualifications training and subsequent professional development training to see if the required timeframes have been met. A simple record check may uncover a major compliance issue.

Subcontractor Exemption Applies Only to Maintenance

All contractors that “stand in the shoes” of a grantee/subrecipient and perform safety- sensitive functions are covered by the regulations and must have a compliant program. Similarly, subcontractors that “stand in the shoes” of a grantee/subrecipient and perform safety-sensitive functions are also included. The only exception to this provision is second tier maintenance contractors which were specifically excluded. This exclusion exists only in relation to maintenance subcontractors because of the specific and unique nature of these vendors. This exclusion does not pertain to any other safety-sensitive subcontractors (e.g., operations, security).

FOR YOUR INFORMATION

Where to Find? .....

Urine Specimen Collection Guidelines Office of Drug and Alcohol Policy and Compliance
United States Department of Transportation
Version 1.0
August 2001www.dot.gov/ost/dapc
Fax on Demand
(800) 225-3784
Substance Abuse Professional Guidelines
Office of Drug and Alcohol Policy and Compliance
United States Department of Transportation
August 2001www.dot.gov/ost/dapc
Fax on Demand
(800) 225-3784

The information presented on this page should be used to update Chapters 4 and 10 of the revised Implementation Guidelines.

Common Audit Findings—Old and New

In 1997, the Office of Safety and Security began auditing grantee drug and alcohol testing programs to determine compliance with the FTA drug and alcohol testing regulations. The audit process has evolved over time and the process continues to be streamlined, shortened and made more grantee-friendly.

The audits give FTA the opportunity to identify common compliance issues that can be the focus of training, information sharing, and other technical assistance efforts. Many of the compliance issues commonly found in recent audits are related to the regulatory revisions that went into effect in August, 2001 while others have plagued grantees since the program was first implemented. The following list of procedural errors is a sampling of common audit findings.

However, §40.241(b) requires the alcohol test to be conducted first. Substance Abuse Professional (SAP) referrals are required anytime a covered employee or applicant tests positive or refuses a test (§40.287). Many transit systems Drug and Alcohol Program Managers (DAPM) fail to refer applicants to a SAP.

Random testing is performed during limited hours and days of the week rather than being reasonably spread throughout the year, week and day so as not to establish a predictable pattern (§655.45(g)).

Post-accident tests are often conducted when the FTA criteria for an accident are not met (§655.44). If transit systems choose to exceed the FTA requirements for post-accident tests, they may do so if the test is conducted under the employer’s own authority and a non-DOT Custody and Control Form is used. Many transit system Designated Employer Representatives (DER), Medical Review Officers (MROs), specimen collectors, and Breath Alcohol Technicians (BATs) convey confidential information over the telephone using voice recognition as the only means of identifying the other party. Voice recognition is not an acceptable method of identification. You must establish a mechanism to establish the identity of the other party (§40.167 (b)(2) and §40.255(b)(1)). Auditors recommend a password system be used to confirm identities.

BATs and urine specimen collectors commonly fail to explain the basic collection procedures to the employee or show the employee the written instructions provided on the back of the Alcohol Test Form (ATF) or the Custody and Control Form (CCF) as required (§40.61(e) and §40.241(e)).

Other common audit findings will be discussed in future issues of the Updates.

Policy on Negative Dilute Must Be Stated

A dilute specimen is a specimen with creatinine and specific gravity values that are lower than expected for human urine. If the test is reported as a dilute positive, the test should be treated as a verified positive test result. If the test is reported as a negative dilute, the employer may, but is not required to direct the employee to take another test. The retest must not be conducted under direct observation.

Since the regulation gives discretion in this manner, the employer must establish policy indicating whether retests will be required for negative dilutes. All employees must be treated the same for this purpose and must be informed in advance of the policy. A covered employer may not remain silent on this issue.

RX & OTC MEDICATIONS

FTA Drug and Alcohol Regulation Updates
Issue 30, page 7

Dietary Supplements—Are They Safe?

According to the Dietary Supplement and Education Act (DSHEA) of 1994, a dietary supplement is a product taken by mouth that contains an ingredient intended to supplement the diet such as vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements are considered foods and not drugs. Supplements come in every imaginable form including teas, powders, tablets and capsules.

According to the National Institutes of Health (NIH), some 24,000 to 30,000 products are currently on the market. These products are sold in pharmacies, health food stores and grocery stores, over the internet and in physician’s offices. The Food and Drug Administration (FDA) reported that in 2004, millions of Americans took dietary supplements, accounting for $3.2 billion dollars in sales.

Most Americans believe that dietary supplements offer health benefits and assume they cause no serious harm. This is true in most cases, but the dangerous effects of some have been well known for more than a decade. Several products available in the United States have been banned in other parts of the world including Asia, Europe, and Canada. The FDA oversees safety, manufacturing and product information. The NIH coordinates research on dietary supplements. According to the American Medical Association, however, supplements are “virtually unregulated” and there is no central source of information about adverse reactions to supplements. While drug manufacturers are required to prove their products are safe before being marketed, DSHEA makes the FDA prove that supplements on the market are unsafe. FDA’s job is difficult because manufacturers are not required to report adverse events, very little information is available about the safety record of most supplements and the standards to demonstrate that a supplement is hazardous are very high.

Supplements do not have to be tested for safety or efficacy, nor do they have to be approved by the FDA before they can be sold to the public. Almost all supplements can produce some unpleasant side effects. Warning labels on a supplement’s potential side effects are not required, even for products with known serious hazards. There is no assurance that the contents of a supplement are pure and provided in the quantities stated on the label. Contaminants are routinely found in supplements.

Supplements are often sold under a variety of names and sold in combinations without all ingredients listed. Many have the perception that because dietary supplements are natural, they are safe. In reality, many act like drugs and have similar risks. The FDA has recorded more than 2,500 reports of side effects and 79 deaths associated with dietary supplements. In addition, the NIH has identified side effects in some supplements that raise fitness for duty concerns. For example, Kava and Valerian are listed as having drowsiness and dizziness as side effects.

In May 2004, a Consumer Reports article, “Dangerous Supplements: Still At Large,” identified twelve supplements that should be avoided and listed long-term effects of some herbal remedies that are easily obtainable. The article can be found at www.consumerreports.org/main/display_report.jsp. The unsafe supplements listed are the following.

Resource Materials

Who Should Be Receiving This Update?

In an attempt to keep each transit system well-informed, we need to reach the correct person within each organization. If you are not responsible for your system’s Drug and Alcohol program, please forward this update to the person(s) who is and notify us of the correct listing. If you know of others who would benefit from this publication, please contact us at the following address to include them on the mailing list. This publication is free.